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Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

WithdrawnPhase 2

Sponsor: Regeneron Pharmaceuticals

Conditions: Hodgkin Lymphoma

Interventions: Cemiplimab, Involved-site radiotherapy (IS-RT)

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL). Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Histologically proven classical HL
* First diagnosis, no previous treatment
* Stage I-II without risk factors as defined in the protocol

Key Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
* Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment as defined in the protocol
* Pregnancy or breast-feeding
* Non-compliance as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply